FDA Adverse Event
Injury
Summary report: N
ADAPTA DR
MDR report key: 1925534
·
Received December 14, 2010
Report
- Report Number
- 6000144-2010-06324
- Event Type
- Injury
- Date Received
- December 14, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- NVZ
- PMA / PMN Number
- P980035/S043
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING TWITCHING ON THE LEFT ARM AND DEVICE POCKET LOCATION. THE PHYSICIAN WILL PROGRAM THE DEVICE AND TEST FOR SENSATION. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN PERFORMED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADAPTA DR | IMPLANTABLE PULSE GENERATOR | NVZ | MEDTRONIC MED REL, INC. | ADDR01 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Required Intervention | 4074 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD |